Supplement trade associations expect the recently introduced adverse event reporting legislation for dietary supplements and OTC drugs to have the greatest effect on the supplement industry's reputation over time by developing an official record of safety.

"I don't think [AER requirements are] going to have a significant effect on our reputation overnight. But I think what it will do is that if you look out five years...we're going to have a five-year track record that's well-documented, in the public view, of really how few serious adverse events there are for dietary supplements," Council for Responsible Nutrition President Steve Mister stated in a recent interview with "The Tan Sheet".

American Herbal Products Association President Michael McGuffin concurred saying, "I think that what's going to happen is that five years from now...you're going to look at the body of evidence and say, 'There are not very many adverse events associated with these goods.'"

"In five years, this is going to be seen as one of the smartest things that we ever did or...well, it's hard for me to look at the 'or' because I just don't see how we would end up with lots and lots of serious reports," United Natural Products Alliance Executive Director Loren Israelsen agreed.

The "Dietary Supplement & Nonprescription Drug Consumer Protection Act" (S 3546) was introduced by Sens. Orrin Hatch (R-Utah), Tom Harkin (D-Iowa) and Richard Durbin (D-Ill.) June 21, and would require manufacturers of all OTC drugs and dietary supplements to report serious adverse events associated with those products to FDA (¹ Also see "Bipartisan AER Bill Requires Reporting For All OTC Drugs, Supplements" - Pink Sheet, 26 June, 2006., p. 3).

Senate Health Committee Chairman Michael Enzi (R-Wyo.) and Ranking Member Edward Kennedy (D-Mass.) also are cosponsors of the legislation which was passed by the Senate Health Committee June 28.

The bipartisan legislative effort was met with overwhelming support from both industry and consumer groups.

One of the bill's provisions most enthusiastically received by industry is the federal preemption provision, which would create a nationally standardized version of the serious adverse event reporting system and not allow states to apply their own AER regulations to OTC and supplement manufacturers.

"The industry's view is very simple. It makes no sense to have potentially 51 reporting requirements. That would be just enormously burdensome and redundant," Israelsen explained.

The industry is adamant about the importance of a national AER system and it is widely believed that the preemption provision will remain in the final version of the bill. Otherwise, there would be some strong objections if the provision were taken out.

"And so bottom line is, will [the federal preemption provision] stay in the final bill?....Is it a dealbreaker? Either it is, or it's very close to one," Israelsen stated.

"I think it's pretty hard to take this bill as a package and say that there are pieces of it that shouldn't be there," Mister concurred.

The supplement trade groups also generally are in consensus about whether FDA will be able to handle the new legislation if it becomes law.

McGuffin stated that he thinks the agency can, in fact, "handle the enforcement responsibility" required by the bill.

During the press conference announcing the introduction of the bill, Sen. Hatch estimated that the program would cost FDA approximately $2 mil. per year to maintain, according to National Nutritional Foods Association Executive Director and CEO David Seckman.

"At the press conference, Sen. Hatch mentioned that although he didn't actually have a scoring on the bill, to the best of his knowledge it would cost about $2 mil. a year," Seckman explained.

"Obviously, he wasn't 100% sure of that, but [FDA does] have adequate resources and Sens. Hatch, Harkin and Durbin all indicated a great desire to help [the agency] secure any additional funding, even though that is a fairly low amount within a very large FDA budget," he stated.

Indeed, it appears that the senators already have begun to request more funding for FDA in anticipation of the proposed legislation's passage.

The Senate Appropriations Committee recently recommended that FDA's Center for Food Safety & Applied Nutrition be allocated $5.3 mil. in funding for its Adverse Event Reporting System (CAERS) for 2007. The amount is $1 mil. higher than the President's budget request for the center (² 'The Tan Sheet' June 26, 2006, In Brief).

The increase in funding for CAERS comes as a result of "a request by Sen. Hatch to increase the budget in anticipation of the legislation passing," NNFA stated.

Although most industry and consumer groups support the legislative effort, other groups such as the American Association for Health Freedom do not agree with the idea of a mandatory reporting system for adverse events related to dietary supplements.

AAHF, a nonprofit group that "advocates citizen access to a wide range of healthcare and prevention methods," feels that the bill "falls short of the public's best interest," according to a July 10 release.

The group fears that supplements could be unfairly blamed for adverse events submitted by consumers and that the intervention of a healthcare professional to determine the event is necessary.

AAHF also claims that the proposed legislation is "a demonstration of the federal government wasting money to protect the public from a relatively small health threat on the part of dietary supplements," as food is associated with more AER and deaths each year than supplements.

However, supplement trade groups point out that the legislation carries a prohibition against false reports as well as limits submissions to serious adverse events only.

Additionally, the bill provides safeguards for manufacturers, with a specific section that clarifies that the submission of an adverse event is not an admission that the product was involved with the event.

In addition to these safeguards against abuse of the system, industry's support for the bill is in part a result of trust in supplements' safety profile on the whole, Israelsen stated.

"I think it boils down to 'how confident are we in the safety of our own products?'" Israelsen postulated.

Based on experience, "we have a safety record that is incredibly remarkable," he concluded.

- Jessica Lake

AER Bill Will Provide Documented History Of Supplement Safety – Industry

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